PMA P010012S416
- Device
- ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S416
- Product code
- NIK
- Decision date
- 2016-06-09
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for a shelf-life extension to 18 months.
Current openFDA PMA Record#
- Device
- ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S416
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-06-09
- Decision code
- APPR
- Date received
- 2016-04-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a shelf-life extension to 18 months.